Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than one use...

The FDA mandates the use of UDI 2D data matrix barcodes for most medical devices and pharmaceutical products. The UDI must be directly marked on the device packaging or label …

2025年3月10日 · Fortunately the FDA UDI requirements allow for use of 2-dimensional (2D) barcodes. Compared to linear barcodes, 2D barcodes can encode all of the required UDI data …

According to the International Medical Device Regulators Forum (IMDRF), a Unique Device Identification (UDI) system is intended to provide a single, globally harmonised system for …

2021年3月24日 · UDI is a Two-part Barcode. The Unique Device Identifier or UDI is a barcode, most often containing two data sets. The primary data set is the Device Identifier (DI); the …

The GS1 UDI barcode combines the Device Identifier (DI), also known as the GTIN by GS1.org, and the Production Identifier (PI).

2024年6月28日 · Comprehensive list of links to the UDI rule and guidances, training for industry, UDI and GUDID technical resources, and dockets.

A UDI is a unique numeric or alphanumeric code that consists of two parts: • a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or …

2017年3月24日 · A UDI code aims at unambiguous identification of a specific medical device. To ensure a globally standardized and harmonized system, the UDI code must be issued under …

企业开通gs1 udi服务平台，可实现在一个平台完成从厂商识别代码申请、udi编码、备案至中国商品信息服务平台及药监局数据库、信息管理、标签设计、打印喷码等udi实施全流程。